{"id":3629,"date":"2025-06-17T20:46:57","date_gmt":"2025-06-17T20:46:57","guid":{"rendered":"https:\/\/rarus.health\/?p=3629"},"modified":"2025-06-17T21:25:43","modified_gmt":"2025-06-17T21:25:43","slug":"rare-diem-virtual-summit-2025-latin-americas-rare-disease-clinical-trials-advantage","status":"publish","type":"post","link":"https:\/\/rarus.health\/en\/2025\/06\/17\/rare-diem-virtual-summit-2025-latin-americas-rare-disease-clinical-trials-advantage\/","title":{"rendered":"Rare DIEM Virtual Summit 2025: Latin America\u2019s Rare-Disease Clinical Trials Advantage"},"content":{"rendered":"<p>By Elmira Safarova, PhD | Founder &amp; CEO, Rarus Health<\/p>\n<h3>Setting the Stage \u2014 Only 5.4 % of Rare-Disease Clinical Trials Happen in Latin America. That Must Change.<\/h3>\n<p>Last week I had the honor of speaking at the <strong>Rare DIEM (Diseases In Emerging Markets) Virtual Summit 2025 by <a href=\"https:\/\/farmaconglobal.com\/\" target=\"_blank\" rel=\"noopener\">Farmacon Global<\/a><\/strong>, where researchers, patient advocates, regulators, and industry leaders came together to confront a stubborn paradox:<\/p>\n<ul>\n<li><strong>Latin America (LATAM) possesses every ingredient for high-impact clinical research<\/strong>\u2014diverse genetics, centralized public-health systems, motivated investigators, and recruitment costs up to <strong>40 % lower<\/strong> than in the US or EU.<\/li>\n<li>Yet barely <strong>one in twenty clinical trials<\/strong> takes place in the region, and even fewer focus on orphan and ultra-rare diseases.<\/li>\n<\/ul>\n<p>Our panel\u2014<em>\u201cData Sovereignty &amp; AI in LATAM Clinical Trials: Protecting Patients and Institutions\u201d<\/em>\u2014looked at how we can unlock that potential without repeating the extractive models of the past. Below are my main take-aways and the concrete steps Rarus Health is taking to accelerate the shift.<\/p>\n<h2>1. LATAM\u2019s Competitive Edge Is Real\u2014and Urgent<\/h2>\n<table>\n<thead>\n<tr>\n<th>Advantage<\/th>\n<th>What It Means for Sponsors<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Cost efficiency<\/strong><\/td>\n<td>Up to 40 % lower per-patient cost while meeting ICH-GCP standards.<\/td>\n<\/tr>\n<tr>\n<td><strong>Fast site activation<\/strong><\/td>\n<td>Countries such as Mexico and Chile routinely green-light trials in &lt;120 days, shaving months off time-to-market.<\/td>\n<\/tr>\n<tr>\n<td><strong>Rapid recruitment<\/strong><\/td>\n<td>Treatment-na\u00efve populations and national health registries make it easier to identify eligible patients.<\/td>\n<\/tr>\n<tr>\n<td><strong>High-value therapeutic gaps<\/strong><\/td>\n<td>Neuromuscular and neurodevelopmental disorders remain under-represented, offering \u201cblue-ocean\u201d space for sponsors willing to innovate.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Yet these advantages stall when <strong>regulatory fragmentation, limited natural-history data, and a lingering trust gap<\/strong> keep sponsors on the sidelines.<\/p>\n<h2>2. Data Sovereignty + AI: From Buzzwords to Blueprint<\/h2>\n<p>During the panel we agreed on three principles:<\/p>\n<ol>\n<li><strong>Federated data models<\/strong>Keep data where it is generated; move only encrypted insights for analysis. This respects national sovereignty and avoids mass data exports that erode trust.<\/li>\n<li><strong>AI-driven patient matching<\/strong>Modern machine-learning models can scan electronic records and patient-reported outcomes to identify trial-ready cohorts in weeks rather than months\u2014<em>if<\/em> we have structured, consented data to feed them.<\/li>\n<li><strong>Recruitment-enabling education<\/strong>Families are willing partners when they understand how their data translates to faster diagnoses, trials, and therapies. Education must be built into every protocol, not bolted on later.<\/li>\n<\/ol>\n<blockquote><p>\u201cTrust emerges when patients see their data as a bridge to better care\u2014not an asset extracted from them.\u201d \u2014My closing line at the summit<\/p><\/blockquote>\n<h2>3. What the Ecosystem Still Lacks<\/h2>\n<ul>\n<li><strong>Regional harmonization<\/strong>. Separate ethics boards and import rules force sponsors to run country-by-country gauntlets.<\/li>\n<li><strong>Longitudinal access<\/strong>. Advocacy groups feel betrayed when a study drug never makes it to local formularies. Compassionate-use and early-access programs must be planned up-front.<\/li>\n<li><strong>Shared infrastructure<\/strong>. Only a handful of high-income metros have the biobanks, genetic testing, or telehealth reach needed for rare-disease trials.<\/li>\n<\/ul>\n<h2>4. How Rarus Health Is Closing the Gaps<\/h2>\n<table>\n<thead>\n<tr>\n<th>Challenge<\/th>\n<th>Rarus Health Solution<\/th>\n<th>Impact<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Fragmented patient data<\/td>\n<td><a href=\"https:\/\/rarus.health\/en\/reales\/\"><strong>Project REALES<\/strong><\/a>\u2014a patient-driven neuromuscular registry that standardizes clinical, genomic, and real-world data across LATAM in Spanish.<\/td>\n<td>Provides the structured, consented datasets AI needs for rapid cohort discovery.<\/td>\n<\/tr>\n<tr>\n<td>Trust &amp; transparency<\/td>\n<td><strong>Dynamic, GDPR-style consent<\/strong> delivered via web app, plus plain-language dashboards so families see how their data is used.<\/td>\n<td>Converts participants into long-term partners and ambassadors.<\/td>\n<\/tr>\n<tr>\n<td>Natural-history evidence<\/td>\n<td><strong>Longitudinal follow-up modules<\/strong> co-designed with caregivers and clinicians.<\/td>\n<td>Generates endpoints and PROs that regulators recognize, de-risking trial design.<\/td>\n<\/tr>\n<tr>\n<td>Recruitment bottlenecks<\/td>\n<td><strong>AI-enabled matching engine<\/strong> that sits atop our registry and hospital EHR integrations.<\/td>\n<td>Sponsors receive pre-qualified cohorts within a single IRB framework.<\/td>\n<\/tr>\n<tr>\n<td>Education gap<\/td>\n<td>Webinars, micro-courses, and local ambassador programs (e.g., Moebius Chile, Club Pompe International, Dravet LATAM Foundation).<\/td>\n<td>Builds \u201crecruitment-enabling education\u201d into community culture and speeds enrollment.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Call to Action\u2014Let\u2019s Build the Next 1,000 Rare-Disease Trials in LATAM<\/h3>\n<p>If you are:<\/p>\n<ul>\n<li>A <strong>pharma or biotech<\/strong> seeking faster, more diverse recruitment<\/li>\n<li>A <strong>CRO<\/strong> looking to streamline multi-country operations<\/li>\n<li>A <strong>patient organization<\/strong> ready to turn lived experience into scientific power<\/li>\n<\/ul>\n<p>\u2026then I invite you to partner with us.<\/p>\n<p><a href=\"https:\/\/calendly.com\/elmira_safarova\/call-with-rarus-health\" target=\"_blank\" rel=\"noopener\"><strong>Book a meeting with me<\/strong> to explore how we can accelerate your next rare-disease study<\/a><\/p>\n<p>Together we can transform Latin America from a 5 % footnote into a global powerhouse for ethical, patient-centered innovation\u2014while bringing life-changing therapies closer to the people who need them most.<\/p>\n<p><em>Con coraz\u00f3n y ciencia,<\/em><\/p>\n<p><strong>Elmira Safarova, PhD<\/strong><\/p>\n<p><!-- notionvc: dd3917f5-1288-4284-b2f5-a79fda07810e --><\/p>","protected":false},"excerpt":{"rendered":"<p>Discover key takeaways from Rare DIEM 2025 and how Rarus Health\u2019s Proyecto REALES accelerates patient-centered rare-disease trials in Latin America.<\/p>","protected":false},"author":7,"featured_media":3627,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9],"tags":[32,31,30,28,29],"class_list":["post-3629","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-ai-in-healthcare","tag-data-sovereignty","tag-latin-america-clinical-trials","tag-rare-diem-2025","tag-rare-diseases"],"acf":[],"_links":{"self":[{"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/posts\/3629","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/comments?post=3629"}],"version-history":[{"count":3,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/posts\/3629\/revisions"}],"predecessor-version":[{"id":3632,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/posts\/3629\/revisions\/3632"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/media\/3627"}],"wp:attachment":[{"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/media?parent=3629"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/categories?post=3629"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rarus.health\/en\/wp-json\/wp\/v2\/tags?post=3629"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}